Continuous Care Intervention in Primary Care to Improve Type 2 Diabetes Control in Terres de l'Ebre, Catalonia

T2DM is a highly prevalent chronic disease, accounting for approximately 90% of all diabetes cases, and is primarily managed in the primary care setting. The complexity of optimizing metabolic control in T2DM has increased, as current guidelines recommend a multifactorial approach that addresses not only glycemic control but also cardiovascular risk and multimorbidity. Glycosylated hemoglobin (HbA1c) remains the principal marker for assessing glycemic control and predicting diabetes-related complications.

Despite the availability of evidence-based clinical practice guidelines, their implementation in routine care is often suboptimal due to factors such as limited time, resources, clinical inertia, and challenges with patient adherence. Interventions targeting healthcare professionals and organizational processes-such as structured training, audit and feedback, and system-level changes-have shown promise in improving metabolic outcomes, particularly among patients with suboptimal glycemic control.

This study is a randomized, parallel-group clinical trial designed to evaluate the effectiveness of a continuity of care intervention led by the Endocrinology Service at HTVC, in collaboration with primary care centers in the Terres de l'Ebre health region. Primary care centers will be randomized to either the intervention or control group.

The intervention consists of structured, multidisciplinary training and feedback provided by endocrinologists and nurse educators to primary care physicians and nurses. Training sessions are delivered in modules that combine theoretical and practical content, with a focus on up-to-date diabetes management strategies and the needs of each primary care center. The endocrinology team includes endocrinologists, nurse educators, and a specialist nurse from the Diabetic Foot Unit. Training will be delivered onsite at intervention centers in scheduled sessions over a one-year period.

A qualitative component is integrated into the study, involving focus groups with participating primary care professionals before and after the intervention. This aims to gather insights on professional perspectives, identify barriers and facilitators, and inform the adaptation and future implementation of the intervention.

The primary outcome is improvement in HbA1c, with secondary outcomes including additional patient health indicators, professional knowledge and engagement, and organizational variables. Data collection will occur at baseline, 6, 12, and 24 months. All data will be anonymized to ensure confidentiality.

This study aims to provide evidence on the effectiveness of a multidisciplinary, continuity of care intervention in improving metabolic control for adults with T2DM in a real-world primary care setting.

• Change in total cholesterol and LDL cholesterol [Time frame: At enrollment, 6, 12, and 24 months after enrollment.]
• Change in systolic and diastolic blood pressure [Time frame: At enrollment, 6, 12, and 24 months after enrollment.]
• Change in smoking status [Time frame: At enrollment, 6, 12, and 24 months after enrollment.]
• Change in Body Mass Index (BMI) [Time frame: At enrollment, 6, 12, and 24 months after enrollment.]
• Percentage of participants adherent to screening protocol for T2DM complications [Time frame: At enrollment, 6, 12, and 24 months after enrollment.]
• Referrals to the Diabetic Foot Unit [Time frame: At enrollment, 6, 12, and 24 months after enrollment.]
• Emergency assistance for metabolic decompensations [Time frame: At enrollment, 6, 12, and 24 months after enrollment.]
• Number of hospital referrals from primary care [Time frame: At enrollment, 6, 12, and 24 months after enrollment.]
• Medication changes [Time frame: At enrollment, 6, 12, and 24 months after enrollment.]
• Number of patient visits to primary care [Time frame: At enrollment, 6, 12, and 24 months after enrollment.]
• Professional perceptions of relevance, feasibility and impact of the Continuity-of-Care intervention [Time frame: Pre-intervention and 1 month post-intervention]
• Professional experiences with implementing the Continuity-of-Care intervention, including perceived barriers and facilitators [Time frame: Pre-intervention and 1 month post-intervention.]